The immunogenicity of the ChAdOx1 nCoV-19 vaccination in participants with underlying comorbidity diseases: A prospective cohort study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) increases mortality rates in older adults and those with comorbidities. Individuals with certain comorbidities may have a poor immune response and require early booster vaccines. We aimed to assess the immune response after two doses of ChAdOx1 nCoV-19 vaccine, at 84-day intervals, in participants with the following comorbidities; diabetes mellitus; obesity; cardiovascular disease; chronic kidney disease; rheumatological disease; cirrhosis; hematological disease; hematological malignancy; or solid malignancy. The study was conducted at Chulabhorn Hospital in Thailand, with healthy healthcare workers serving as the control group. Of the 769 participants, 352 were in the healthy cohort and 417 were in the comorbidity cohort, all received at least one dose of vaccine. Anti-RBD total antibody levels were evaluated on Day 0, Day 84, and Day 112. The results at Day 112 (4 weeks after the second dose) showed that individuals with comorbidities had a poor immune response compared to healthy individuals, especially those with hematological malignancy and solid malignancy. The geometric mean concentration (GMC) of anti-RBD antibody in the comorbidity cohort was significantly lower than that in the healthy cohort: 433.66 BAU/ml (95% CI 334.62-562.01) versus 1096.14 BAU/ml (95% CI 1010.26-1189.33), respectively. The geometric mean ratio (GMR) between the two cohorts was 0.40 (95% CI 0.30-0.52, p < .001). This study concluded that individuals with comorbidities, particularly hematological and solid malignancies, had poor immune responses and may require an early booster vaccine to prevent infection and death.

Dynamics of anti-RBD (anti-receptor binding domain) levels in diabetes patients following the ChAdOx1 nCoV-19 vaccine (AZD1222) in the Thai population.

The ChAdOx1 nCoV-19 vaccine (AZD1222) was used in Thailand during the early outbreak of coronavirus disease 2019 (COVID-19). A previous study showed a low immune response in diabetes patients after the first dose of the AZD1222 vaccine. Furthermore, humoral immune responses after the second vaccination were inconsistent. This study evaluated the immunogenicity following the first and second doses of the AZD1222 vaccine in people with type 2 diabetes (T2D) compared with the general population of Thailand. This was a prospective, single-center cohort study. 59 adults with T2D and 118 age- and sex-matched healthcare personnel were eligible. The participants received two doses of AZD1222 12 weeks apart. Antibodies against the receptor-binding domain (anti-RBD) of the SARS-CoV-2 spike protein, using an automated electrochemiluminesence immunoassay (ECLIA), were measured at baseline, 8 and 12 weeks after the first dose of vaccine, and 4 weeks after the second dose of vaccine. The anti-RBD levels were reported as the geometric mean concentration (GMC) and compared between groups using the geometric mean ratio (GMR). A total of 177 participants were included: The average age of 59 T2D patients was 60.1 years (SD: 11.4), and 31 (52.5%) of them were female. The GMC of anti-RBD 8 and 12 weeks after the first vaccination were significantly lower in T2D (week 8 60; 17.05 BAU/mL, 95% confidence interval [CI] 11.1-26.19, P = 0.035, week 12; 24.68 BAU/mL, 95% CI 16.4-37.0, P = 0.002) than in those without diabetes (week 8; 29.79 BAU/mL, 95% CI 22.07-40.42, week 12; 50.67 BAU/mL, 95% CI 40.62-63.20). However, there was no difference in the GMC of anti-RBD 4 weeks after the second vaccination among groups (T2D; 687.95 BAU/mL, 95% CI 462.7-1022.7, Normal; 697.95 BAU/mL, 95% CI 583.7-834.5, P = 0.947). In both groups, the GMC of anti-RBD was persistently high without decline 12 weeks after the first vaccination. Albuminuria was a major factor related to low humoral immune responses in T2D patients after the second dose of AZD122 vaccine (the GMR was 0.29, 95% CI 0.08-0.98, P = 0.047) whereas the HbA1C level and age were not. Immunogenicity in T2D cases was lower than in the normal population after the first dose of the AZD1222 vaccine. The two doses of AZD122 vaccine induced immunity in T2D equal to that of normal individuals in Thailand. People with diabetes should be boosted as soon as possible to induce adequate immunity to prevent COVID-19 infection.

Immune Response to CoronaVac and Its Safety in Patients with Type 2 Diabetes Compared with Healthcare Workers.

BACKGROUND: Vaccines for SARS-CoV-2 have been critical for preventing disease. Previous research showed patients with diabetes have impaired immunity. This study aimed to determine the immunity to coronavirus after CoronaVac by comparing patients with type 2 diabetes (T2D) and healthcare workers (HCW). MATERIALS AND METHODS: A prospective cohort study evaluated immune responses and safety after two doses of CoronaVac in T2D and HCW groups at Chulabhorn Hospital. The levels of total antibodies against the receptor-binding domain (anti-RBD) of the SARS-CoV-2 spike protein at baseline and 4 weeks after vaccination were collected. The level of anti-RBD concentrations was reported as geometric mean concentration (GMC) and compared between groups using the geometric mean ratio (GMR). RESULTS: 81 participants were included; 27 had T2D and 54 were HCW. After complete vaccination, anti-RBD concentrations were not significantly different between T2D (57.68 binding antibody units (BAU)/mL, 95% confidence interval (CI) = 29.08; 114.44) and HCW (72.49 BAU/mL, 95% CI = 55.77; 94.22) groups. Subgroup analysis showed the GMC of anti-RBD was significantly lower in T2D patients with dyslipidaemia (50.04 BAU/mL) than in T2D patients without dyslipidaemia (341.64 BAU/mL). CONCLUSIONS: The immune response at 4 weeks after two doses of CoronaVac did not significantly differ between patients with T2D and HCW.

Antibody levels in people with diabetes after one dose of the ChAdOx1 nCoV-19 (AZD1222) vaccine.

Patients with diabetes and coexistent coronavirus disease 2019 (COVID-19) have a higher risk of COVID-19 complications. Therefore, it is critical that sustained and effective immunogenicity against COVID-19 is achieved in such patients. This study evaluates the antibody response for 56 days after the first dose of the AZD1222 vaccine in subjects with and without diabetes to assess the potential risk of delaying the second dose. This study included 282 people who received one dose of AZD1222. The geometric mean concentration of antibodies specific for severe acute respiratory syndrome coronavirus 2 IgG at 56 days was significantly (P < 0.001) lower in people with type 2 diabetes mellitus (T2D; 15.13 BAU/mL, 95% confidence interval [CI] = 10.7-21.4) than in those without diabetes (40.20 BAU/mL, 95% CI = 33.43-48.36), as confirmed by a geometric mean ratio of 0.37 (95% CI = 0.25-0.54). Weaker immune responses were also observed in diabetic patients ≥ 65 years old (10.09 BAU/mL, 95% CI = 6.09-16.71) compared with their younger counterparts (22.31 BAU/mL, 95% CI = 13.98-35.59, P = 0.034). People with T2D had weaker antibody responses than those without diabetes after the first dose of AZD1222. Older age was associated with weaker antibody responses in elderly patients with diabetes.

Sleep variability, 6-sulfatoxymelatonin, and diabetic retinopathy.

PURPOSE: Recent evidence suggests that diabetic retinopathy (DR) is associated with abnormal melatonin regulation, possibly related to dysfunction of the melanopsin-expressing intrinsically photosensitive retinal ganglion cells. This study explored melatonin regulation in type 2 diabetes (T2D) patients with DR and its relation to sleep and circadian functioning. METHODS: Thirty-five participants (10 non-diabetic controls, 10 T2D without DR, and 15 T2D with DR) were recruited. Overnight urine 6-sulfatoxymelatonin (aMT6s) and objective sleep and wrist activity (7-day actigraphy) were obtained. RESULTS: After adjusting for covariates, having T2D with DR was significantly associated with lower urinary aMT6s (ß = - 1.369, p = 0.004) compared with controls, while having T2D without DR was not (p = 0.418). T2D patients with DR reported poorer sleep quality (p = 0.014) and had greater variability of sleep duration (p = 0.017) than others, while no differences were found in sleep duration, efficiency, and rest-activity rhythm. After adjusting for covariates, lower nocturnal aMT6s was significantly associated with greater sleep variability. CONCLUSION: T2D patients with DR exhibited low overnight production of aMT6s which likely contributed to sleep irregularities possibly due to weak circadian signaling. Whether or not melatonin supplementation could improve health in T2D patients with DR remains to be explored.